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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/08/492|
|Active substance :||tocilizumab|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC07 - Tocilizumab
(See WHO ATC Index)
|Indication:||RoActemra, in combination with methotrexate (MTX), is indicated for:|
• the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
• the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.
RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
|Marketing Authorisation Holder:||Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
|EPAR and active package presentations|
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|19/01/2009||Centralised - Authorisation - Decision addressed to Member States||EMEA/H/C/955||(2009)233 of 16/01/2009|
|20/01/2009||Centralised - Authorisation||EMEA/H/C/955||(2009)232 of 16/01/2009|
|15/04/2009||Centralised - Variation (no change in Commission Decision)||EMEA/H/C/955/IB/1|
|29/09/2009||Centralised - Variation (no change in Commission Decision)||EMEA/H/C/955/II/2|
|30/10/2009||Centralised - Variation||EMEA/H/C/955/II/3, 4||(2009)8508 of 28/10/2009|
|12/11/2009||Centralised - Variation (no change in Commission Decision)||EMEA/H/C/955/II/6|
|24/11/2009||Centralised - Variation||EMEA/H/C/955/II/5||(2009)9346 of 20/11/2009|
|29/03/2010||Centralised - Variation (no change in Commission Decision)||EMEA/H/C/955/II/12|
|29/03/2010||Centralised - Variation (no change in Commission Decision)||EMEA/H/C/955/II/11|
|01/04/2010||Centralised - Variation||EMEA/H/C/955/II/8, 9||(2010)2271 of 30/03/2010|
|29/04/2010||Centralised - Variation||EMEA/H/C/955/II/10||(2010)2847 of 27/04/2010|
|08/06/2010||Centralised - Variation||EMEA/H/C/955/II/7||(2010)3708 of 04/06/2010|
|23/12/2010||Centralised - Variation||EMEA/H/C/955/II/14||(2010)9650 of 20/12/2010|
|31/01/2011||Centralised - Variation (no change in Commission Decision)||EMEA/H/C/955/II/16/G|
|23/03/2011||Centralised - Variation||EMEA/H/C/955/II/13||(2011)1933 of 18/03/2011|
|02/08/2011||Centralised - Variation||EMEA/H/C/955/II/15||(2011)5697 of 01/08/2011|
|03/08/2011||Centralised - Variation||EMEA/H/C/955/II/15||(2011)5696 of 01/08/2011|
|26/09/2011||Centralised - Variation||EMEA/H/C/955/II/15||(2011)6938 of 22/09/2011|
|31/05/2012||Centralised - Variation||EMEA/H/C/955/II/22||(2012)3585 of 25/05/2012|
|28/06/2012||Centralised - Variation||EMEA/H/C/955/IB/23|
|Updated with Decision(2012)8707 of 22/11/2012|
|03/12/2012||Centralised - Variation||EMEA/H/C/955/II/27||(2012)8707 of 22/11/2012|
|13/12/2012||Centralised - Variation||EMEA/H/C/955/II/28|
|Updated with Decision(2013)3378 of 30/05/2013|
|03/06/2013||Centralised - Variation||EMEA/H/C/955/II/26||(2013)3378 of 30/05/2013|
|30/09/2013||Centralised - Renewal||EMEA/H/C/955/R/31||(2013)6349 of 25/09/2013|
|23/01/2014||Centralised - Variation||EMEA/H/C/955/II/35|
|Updated with Decision(2014)6265 of 01/09/2014|
|28/04/2014||Centralised - Variation||EMEA/H/C/955/X/30||(2014)2828 of 23/04/2014|
|24/07/2014||Centralised - Variation||EMEA/H/C/955/II/39|
|Updated with Decision(2014)6265 of 01/09/2014|
|30/07/2014||Centralised - Variation||EMEA/H/C/955/IB/40|
|03/09/2014||Centralised - 2-Monthly update||EMEA/H/C/955/II/32||(2014)6265 of 01/09/2014|
|26/03/2015||Centralised - Variation||EMEA/H/C/955/II/38|